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Topical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00418249
First received: January 2, 2007
Last updated: January 3, 2007
Last verified: December 2006
History of Changes
  Purpose
The primary objective of this study is to assess the safety and efficacy of topical AS101 as treatment for Female Androgenetic Alopecia (FAGA) in menopause women.

Condition Intervention Phase
Alopecia
 Drug: AS101
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 2 Study of Topical AS101 for the Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • hair density

Secondary Outcome Measures:
  • Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,
  • Self-administered satisfaction questionnaire
Estimated Enrollment: 40
  Eligibility
Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women in menopause, over 50 years of age.
  • Clinically diagnosed for AGA, according to Ludwig scale I-II.

Exclusion Criteria:

  • Women treated with chronic medications.
  • Use of Minoxidil within 3 months prior to entering study.
  • Women who have underwent hair transplantation.
  • Use of drugs with androgenic or anti-androgenic effects.
  • Any other type of hair loss.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418249

Contacts
Contact: Danny Ben Amitai, MD 972-3-9253770
Contact: Raziel Lurie, MD rlurie@bezeqint.net

Locations
Israel
Not yet recruiting
Tel Aviv, Israel
Contact: Danny Ben Amitai    972-3-9253770      
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Danny Ben-Amitai, M.D. Rabin Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00418249     History of Changes
Other Study ID Numbers: #69 REV 00
Study First Received: January 2, 2007
Last Updated: January 3, 2007

Keywords provided by Rabin Medical Center:
Androgenetic Alopecia
Telogen effluvium
Chronic telogen effluvium
Menopause
Female Androgenetic Alopecia (FAGA)

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 24, 2017